The primary function is to assess the safety of experimental compounds and devices by evaluating their effects on the body fluids and tissues of experimental animals. Acts as a science resource in clinical and anatomic pathology for other AbbVie departments. Develop and conduct those portions of study protocols that deal with anatomic and clinical pathology including not only the collection and evaluation of data regarding gross, microscopic, ultra-structural, and clinical pathology but, lastly, the preparation of comprehensive reports correlating these data.

Responsibilities

• Provide professional consultation to scientific staff of other departments and provide professional supervision to assigned technical areas.
• In cooperation with the Toxicology Department the pathologist designs, directs, conducts, and evaluates studies to determine the potential toxicity of experimental compounds and devices in different species of animals. This involves interpretation of data in the field of pathology (necropsy, histopathology, clinical pathology, electron microscopy, etc.).
• Integrates the anatomic pathology data, clinical pathology data and other study findings to generate a pathology report as a component of the Toxicology report).
• Partner with regulatory toxicologists, pathologists and other functions to develop optimal strategies to address specific toxicology issues as well as select and advance Development compounds.
• Accountable for the interpretation and evaluation of biological data in biological and pharmaceutical research and development, biological control, toxicology, general consultation, and solution of problems in these areas. The accuracy of the interpretations and evaluations is of far reaching importance relative to the product clearance by governmental agencies and possible liabilities.
• Ability to function in multidisciplinary teams to address regulatory queries.
• Serves and/or leads issue resolution teams and participates in due diligence teams.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Serves as early safety representative on drug discovery teams. Predict possible toxicities, develop safety screens to detect, and prepare mitigation strategies to avoid potential toxicities and prioritize the safest compounds for progression to development.